Improving Behavioral Health for Caregivers and Children After Pediatric Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recovery, family roles and routines, and academic functioning; yet US trauma centers do not adequately address these outcomes and a scalable national model of care for these families is needed. This proposal builds on prior research from the investigative team to test a technology-assisted, stepped care behavioral health intervention for children (\<12 years) and their caregivers after PTI, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), via a hybrid type I effectiveness-implementation trial with 348 families randomly assigned to CAARE (n=174) vs. guideline-adherent enhanced usual care (EUC) (n=174).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Caregivers (≥18 years old) of children hospitalized with pediatric injury
Children hospitalized with pediatric injury <12 years old
Screen positive on the ASC-Kids (aged 6-11 years) or PDI Caregiver measure of acute distress.
Disqualifiers
A caregiver whose primary language is not English or Spanish
A cognitive challenge (caregiver or child) that would impair ability to consent
Presence of a self-afflicted injury
Presence of injuries resulting from caregiver abuse or neglect (these patients will follow an alternative treatment path).
Trial design
Design model
Parallel
Treatments tested in this trial
Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)
BehavioralCAARE is a technology-enhanced stepped model of care that is designed to deliver education at the bedside to caregivers of children under age 12 years hospitalized for pediatric injury about mental health recovery after pediatric injury as well as risk assessment and brief intervention for high-risk patients (Step 1), foster symptom self-monitoring and reinforcement of coping skills via mHealth tools (Step 2), screen for caregivers' and children's PTSD and depression 30 days post-injury (Step 3), and provide a referral and warm hand-off to mental health services if needed (Step 4).
Treatment groups
348 Participants
are divided into 2 treatment groupsGroup A: Enhanced usual care (EUC)No intervention 0 interventions
Group B: Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in scores in child self-report and caregiver proxy-report of child Quality of Life (QOL)
PROMIS General Life Satisfaction (Caregiver QOL) consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. The Pediatric Quality of Life Inventory (PEDSQL) consists of 23 items in that comprise four Generic Core Scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). Items on the PedsQL are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life.
Time frame
From enrollment (baseline) to 3-month, to 6-month, until end of treatment at 12-month2
Change in scores in caregiver self-report of PTSD
The Abbreviated PTSD Checklist for DSM-5 (PCL-5) will be used to assess caregiver PTSD. The 20 items are rated on a scale from 0-4, with a total symptom severity score calculated by summing all item scores, resulting in a possible range of 0-80, with higher scores indicating the increase in severity of PTSD in caregivers.
Time frame
From 3-month, to 6-month, until end of treatment at 12-month3
Change in scores in caregiver self-report of caregiver depression
Patient Health Questionnaire (PHQ-8) will be used to assess symptoms of caregiver depression, with scores ranging from 0-24 and higher scores indicating higher depression symptoms.
Time frame
From 3-month, to 6-month, until end of treatment at 12-month4
Change of child externalizing problems from 3 month to 12 month
The investigators will use the BASC-3 Behavioral and Emotional Screening System (BESS) to assess children's externalizing behaviors using the BESS Externalizing Problems Composite scale via self-report (ages 6-11) and caregiver proxy report (ages 2-11). The BASC-3 Behavioral and Emotional Screening System (BESS) uses a Behavioral and Emotional Risk Index (BERI) T score to indicate a student's risk level for behavioral and emotional problems. Normal risk: 60 or lower, elevated risk: 61-70, extremely elevated risk: 71 or higher
Time frame
From 3-month, to 6-month, until end of treatment at 12-monthSecondary outcomes
1
Number of caregivers with service engagement
Mental health care service engagement will be assessed using the National Health Injury Survey (NHIS) mental health service utilization items and also items assessing barriers to healthcare.
Time frame
From 3-month, to 6-month, until end of treatment at 12-month2
Mean number of child missed daycare/school days due to pediatric traumatic injury
Caregiver will report on children's number of school and/or daycare days missed due to the injury
Time frame
At 3-month, 6-month, and 12-month3
Change in caregiver health status
36-item Short Form Health Survey (SF-36) will be used to assess a generic indicator of caregivers' health status assessing physical health, role, social, and mental health function. Higher scores indicate more favorable health state, with scores ranging from 0-100.
Time frame
From enrollment (baseline) to 3-month, to 6-month, to end of treatment at 12-month4
Change in caregiver work and productivity status
A single questionnaire item asking caregivers whether they are working, laid off/looking for work, not working and not searching for employment, a student, a homemaker, volunteering, caretaking for another, retired, hospitalized or in a skilled nursing facility, in jail, disabled, or homeless.
Time frame
From enrollment (baseline) to 3-month, to 6-month, to end of treatment at 12-monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov